Towards simplified regulatory compliance: A comprehensive digital tool for innovators

Lean Entries provides digital tools that allow innovators to consider the industry’s extensive regulatory framework when developing products and services, from early on in their projects.

This enables innovators to make informed and accurate business decisions for their projects, with significant impact on the overall success of the entire venture.

The challenge was the growing complexity of the European regulatory framework, which complicates innovation efforts, especially for small and medium-sized enterprises (SMEs) with small compliance budgets and the academia in their translational research. In the bigger picture, this affects the competitiveness of the entire Union. 

Furthermore, the initial focus of development projects is often elsewhere than on regulation, which is typically perceived as tedious and cumbersome. The regulatory literacy of innovators is often weak, even though an understanding of regulation is critical from the start of a project, as it guides resource allocation and scheduling from early on. In some cases, regulatory issues can even lead to an innovation project being shelved.

The practical implementation of a complex regulatory framework is a challenge for legislators, particularly when it generates overlaps and inconsistencies. When policymakers cannot communicate the rulebook clearly and consistently, our single market fragments.

Regulatory literacy should not be a luxury available only to large firms with large compliance budgets. Regulatory technologies (RegTech) provide a user-friendly approach to navigating the complex regulatory framework. Lean Entries’ goal was to develop a user-friendly and effective RegTech product to empower innovators with clarity and a sense of control. The tools help them to assess how the AI Act, the Data Act, or the European Health Data Space (EHDS) Regulation affect their organisations, while their previous tools on the MDR and IVDR add a significant layer of regulatory knowledge for health tech providers.

Lean Entries has, in a joint action with various public and private parties in Finland and Denmark, under the leadership of the Finnish Innovation Fund Sitra, developed digital tools that enable innovators to ensure that their products or services comply with the AI Act, Data Act, and European Health Data Space (EHDS) Regulation, from early on in their projects. 

Lean Entries needed knowledgeable partners to enable the validation of their tools and to receive feedback from end users. HealthHub Finland held the in-depth knowledge and financial resources to support the development of the tools, connect end users and increase the visibility of the joint action and the tools in webinars and through other channels.

The tools take into account all regulations and related official guidelines down to the sub-clause level, complete with cross-references. This provides the user with a clear picture of the regulatory impact on the innovation they are developing.

Thanks to the user-friendly UI of the ENTRIES tools, it only takes a few minutes to identify the regulatory framework. The tools organise the complex body of legislation into clear and instructive entities, thus improving the user's regulatory literacy.

The tools provide direct links, so users can conveniently check the legislation at any time. The ENTRIES e-tools can also generate a report of the applicable requirements with full references for the user’s specific product. This, for the health tech sector, also includes draft regulatory strategy and an estimated timeline for the project's completion. This facilitates communication with investors, authorities and other stakeholders.

The ENTRIES e-tools enable innovators to conduct thorough regulatory requirement reviews for their development projects in minutes, substantially speeding up project execution and reducing project costs.

The ENTRIES tools have been very well-received by users. They are widely regarded as user-friendly and effectively clarify legislative requirements. Here are examples of feedback from the end users, with some specifically on the AI Act tool:

• “The tool is really functional and easy to use!"
• "It nicely shows you the effects of the AI Act, and what kind of things should be taken into account in the development work."
• "Makes the requirements of the AI Act very concrete."
• “With ENTRIES you need to think for yourself, instead of the consultant doing the thinking for you.”
• “If I had had access to the Entries platform two years ago, it would have helped me a lot!”
• “Makes learning so easy you cannot get away.”

Potential for broad adoption

While the number of users in the ongoing pilot is still relatively small, the product has significant potential, as there is no other RegTech product on the market that provides such nuanced information and references with examples and terminology, on demand. Lean Entries also provides training and workshops for its users to ensure a fast learning curve. Within the pilot, small businesses and public sector organisations have the opportunity to use the service free of charge until the end of March 2026.

In addition to developers, the ENTRIES tools would also benefit all stakeholders in the development process and, for example, in the deployment of an AI system. Furthermore, the product serves as a suitable risk management tool for investors, as they need to understand the legislative framework within which the product is being developed.

Legislators could use the tool during the legislative drafting phase to check how a proposed new law would impact end users and what connections it has to existing regulations. 

The tools could also be leveraged in innovative procurement, where innovations are co-developed. This would ensure that the procurement is on a sound regulatory footing.

For example, if a hospital develops an AI-based product in collaboration with a third party, it must ensure if and how the product must claim compliance with the MDR or the IVDR. If the product contains AI, the AI Act sets its own requirements for the tool. The EHDS Regulation also imposes requirements related to the holding and the use of health data or interoperability with Electronic Health Record (EHR) systems.

In the future, the ENTRIES e-tools could also support companies looking to expand their operations to the United States or assist US companies expanding into the EU. This would require expanding the legislative database to also cover, for example, FDA regulations.

Dos: 

• There is an apparent demand for RegTech tools, such as the ENTRIES e-tools. Innovators across all sectors need a user-friendly tool to tackle complex, cross-referenced legislation in an easy-to-understand way. During the development of the ENTRIES e-tools, particular attention was paid to user-friendliness and to ensuring that the tool comprehensively covers all regulations and related official guidelines for each respective Act.
• The e-tools are currently offered free of charge to the target groups that benefit the most: SMEs and public sector organisations that do not necessarily have large compliance budgets at their disposal. In this way, in addition to improving regulatory literacy, user feedback can be collected for further development and improvement.
• The product is very comprehensive, and although it is intuitive and easy to use, it is still advisable to offer training and workshops for users and/or consultants, as this facilitates product adoption. Especially in international markets, we have seen the value of local experts, speaking the native language, joining the workshops.
• The ENTRIES e-tools should be available free of charge to innovators through Europe’s existing networks, so that regulatory literacy becomes a shared baseline.

Don’ts

• There is a strong need for products like the ENTRIES e-tools to ensure the competitiveness of the EU. It would be a significant disadvantage if the availability of such nuanced tools was limited, as there is a great need for improved regulatory literacy among small and medium-sized enterprises (SMEs) and translational research teams, which typically have limited compliance budgets.